Care A2 Plus could be forced to reapply for US approval over ‘specific’ infant formula product

One of few infant formula companies greenlit for import says it is making a ‘specific product’ for the US market, but the regulator warns it may have to start from scratch.

Baby formula from a passenger plane arrives in the US in June. Picture: Anna Moneymaker/Getty Images

Care A2 Plus, one of few infant formula manufacturers given the green light to import into the lucrative US market, would need to seek new approvals if it created a special product for Americans.

As first reported in The Australian on Thursday, Care A2 Plus has yet to ship any product to the US three months after being approved to do so – it says the delay is because it is developing a “specific product” for the market.

However, the regulator warns it must reapply for the approval, known as an enforcement discretion, if it makes changes to the product originally greenlit.

Depending on the scale of the changes, the Food and Drug Administration has told the company – which has flagged its intention to list on the ASX – Care A2 Plus may have to begin the approval process from scratch.

“The FDA has outlined to Care A2 Plus the parameters of our enforcement discretion,” an FDA official told The Australian

“If any changes are made, they would need to get approval for those changes from the agency, which may or may not involve an entirely new assessment for enforcement discretion.”

Care A2 Plus is one nine companies globally to receive enforcement discretion and the FDA – known for its rigorous processes – has shown that it can quickly withdraw approval

The agency suspended UK infant formula manufacturer Global Kosher’s import permission in June. The company planned to send 4.8 million cans of its Kendamil branded product. Combined with Care A2 Plus’ commitment, that accounted for 42.4 per cent of the products that have received enforcement discretion.

The FDA has also deferred the applications of A2 Milk and FrieslandCampina, which applied for temporary approval in May. Fonterra is also yet to receive such permission and has since diverted infant formula it had earmarked for the US to New Zealand.

Parents are still struggling to access infant formula, after the biggest player in the US, Abbott Laboratories, shut down its factory in Michigan in February on contamination concerns and in June after the site was flooded.

Three manufacturers dominate the US market. Abbott Laboratories is the biggest player with 49.5 per cent share, followed by Mead Johnson with 20.6 per cent and Perrigo with 11.9 per cent.

Care A2 Plus – which was founded in 2019 – previously said it expected to send its first shipment of infant formula to the US in the first week of August.

On Wednesday, the company’s chief executive, Steve Loader, said the company was yet to send any product to the US.

Mr Loader was appointed last month after serving as the director of corporate relations at Regional Express. He attributed the delay to Care A2 Plus developing a “specific product” for the US market rather than sending existing Australian stock, which other companies that have received enforcement discretion – including ASX-listed Bubs and Bellamy’s Organic – have done.

Mr Loader said Care A2 Plus was now expecting to send its first shipment this month. Industry insiders say sourcing raw ingredients and materials to produce infant formula cans have been challenging amid a pandemic-fuelled supply chain crunch and Australia’s shrinking milk pool.

Last month Care A2 Plus’ products were briefly removed from sale at Woolworths but reinstated less than 24 hours later. Its infant formula range was not subject to a compliance or safety recall and continued to be sold at Chemist Warehouse during Woolworths’ withdrawal.

Care A2 Plus made the biggest commitment to send the US product next to nutrition giant Mead Johnston under the Biden administration’s import plan.

The FDA enforcement discretion process has attracted criticism from a group of Republican senators, who have accused the agency of “ignoring” applications when parents are struggling to find product on retail shelves.

The FDA has not granted temporary import approval to any new brands since August 10.

“What’s most concerning is FDA’s decision last month to defer further review of pending applications after taking over a month to respond,” the senators wrote. We understand from several manufacturers that FDA has still not indicated any attempt to review or prioritise increasing domestic production through competition,” the senators said.

After Care A2 Plus announced on Wednesday it was developing a “specific product” for the American market rather than sending existing Australian stock, an FDA official said any changes would need the agency’s approval.